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Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care (I-PRO)

2016年3月29日 更新者：University of Florida

An Integrative and Sustainable Approach to Pain Management in Primary Care

The purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. Practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group).

Providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.

Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.

Primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. Secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.

研究类型

介入性

注册 (实际的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Florida
      • Gainesville、Florida、美国、32607
        • Family Medicine at Hampton Oaks
      • Gainesville、Florida、美国、32608
        • Family Medicine at Haile Plantation
      • Gainesville、Florida、美国、32641
        • Eastside Community Practice
      • Gainesville、Florida、美国、32669
        • Family Medicine at Jonesville

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 89年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Providers at one of six active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015
  • Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Advanced Registered Nurse Practitioner (ARNP), Physician Assistant (PA) or other faculty professional providing primary care services

Exclusion Criteria:

  • Residents or other trainees at one of four active Community Health and Family Medicine locations in the University of Florida Health system Gainesville service area (Hampton Oaks, Eastside, Jonesville, and Haile) between May 1, 2014 and September 1, 2015

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Providers of Novel Care
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
其他：Providers of Novel Care
Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
假比较器：Providers of Usual Care
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
其他：Providers of Usual Care
Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Provider Satisfaction Survey
大体时间：Up to 15 months
This is a 16 item web based questionnaire about general experiences and satisfaction with providing care to patients with chronic noncancer pain. Data will be collected at baseline (June 2014) and monthly thereafter through the end of the study period (July 2014 - September 2015). Provider satisfaction data for both the treatment and control groups will be compared.
Up to 15 months
Patient Satisfaction Survey
大体时间：Up to 15 months
This is a four to five question phone survey (depending on whether patient is seeing a provider in a treatment or control group) about general and pain-specific satisfaction with visit. Data will be collected after each visit for chronic noncancer pain through the study period (July 2014 - September 2015). Patient satisfaction data for both the treatment and control groups will be compared.
Up to 15 months

次要结果测量

结果测量
措施说明
大体时间
Hospital Readmission Rates
大体时间：Up to 5 years
The data will be collected retrospectively for a history of hospital readmission rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Up to 5 years
Lab Orders and Results
大体时间：Up to 5 years
The data will be collected retrospectively for a history of lab orders and results (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data will be
Up to 5 years
Prescribed and Dispensed Medications
大体时间：Up to 5 years
The data will be collected retrospectively for a history of prescribed and dispensed medications (June 2011 - June 2015). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Up to 5 years
Pain Intensity
大体时间：Up to 5 years
The data will be collected retrospectively for a history of pain intensity (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Up to 5 years
Medical Costs
大体时间：Up to 5 years
The data will be collected retrospectively for a history of medical costs (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends.This will include cost of pain related care for charge amounts and billed amounts for specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
Up to 5 years
Health Care Utilization
大体时间：Up to 5 years
The data will be collected retrospectively for a history of health care utilization (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. This will include utilization of specialist services, hospital services, and utilization of non-physician services (e.g., pharmacy, physical therapy, etc.). Data for both the treatment and control groups will be compared.
Up to 5 years
Pain Specialist Referral Rates
大体时间：Up to 5 years
The data will be collected retrospectively for a history of pain specialist referral rates (June 2011 - June 2014). Once the new care model starts for the clinicians, data will be collected at baseline (July 2014) and at the end of the study period (September 2015) for an indication of trends. Data for both the treatment and control groups will be compared.
Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Florida

合作者

Pfizer

调查人员

  • 首席研究员：Christopher A Harle, PhD、University of Florida
  • 首席研究员：Robert W Hurley, MD, PhD、University of Florida
  • 首席研究员：Nicole Marlow, PhD、University of Florida

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年7月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2014年7月7日

首先提交符合 QC 标准的

2014年7月9日

首次发布 (估计)

2014年7月11日

研究记录更新

最后更新发布 (估计)

2016年3月30日

上次提交的符合 QC 标准的更新

2016年3月29日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • IRB201300433
  • 8578749 (其他赠款/资助编号：Pfizer, Inc.)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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